HEALTH - FDA Warns of Accidental Overdose in Dogs from Sileo

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The US Food and Drug Administration (FDA) is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo.

Sileo was put on the market May 2016 and is the first drug the FDA has approved for treating noise anxiety in dogs.

Noise anxiety has been challenging to manage with past options for treatment including behaviour modification, anti-anxiety medicine, tranquilizers and gadgets like the ThunderShirt.

Sileo is packaged in an oral dosing syringe with a ring-stop mechanism on the plunger that must be “dialed” and locked into place in order to set the correct dose for the dog.

Overdose can result if the ring-stop is not fully locked, therefore it is very important that the person administering the product understands how to operate the syringe correctly before giving the product to the dog.

The FDA has received 28 reports involving Sileo overdoses in dogs due to the ring-stop mechanism not properly locking at the intended dose.

While no deaths have been reported, in 15 out of the 28 reports, dogs experienced clinical signs of overdose, including lethargy, sedation, sleepiness, slow heart rate, loss of consciousness, shallow or slow breathing, trouble breathing, impaired balance or lack of coordination, low blood pressure, and muscle tremors.

The FDA is warning that all veterinarians and users of the product should be aware of the possibility of accidental overdose and how to use the syringe applicator properly.

Zoetis, the manufacturer of the drug, has provided online resources which demonstrate the proper operation of the syringe and administration technique in detail for veterinarians at Sileodvmus.com, and for dog owners at Sileodogus.com.

BUSINESS - Zoetis to Expand Manufacturing Capabilities

Zoetis Inc. plans to expand capacity at its Global Manufacturing and Supply facility in Kalamazoo, Mich.

The company will install two new production lines and related operations to manufacture oral tablet and chewable medicines for companion animals.

Having more chewable medications on the market will make any pet owner who has wrestled with a stubborn cat or canine very happy.

Zoetis expects to add up to 45 manufacturing positions in the next three years as a result of the expansion and will spent about $64.5 million on the project.   

“Kalamazoo is home to one of the largest and most important manufacturing sites in Zoetis’ Global Manufacturing and Supply network,” Matthew Everhart, Vice President, Pharmaceutical and Aseptic Operations, Global Manufacturing and Supply at Zoetis, said in a release.

“Locating manufacturing here gives us continued access to a highly skilled and diverse workforce which is essential to managing a global animal health company.”

The Michigan Economic Development Corporation (MEDC) awarded Zoetis a Business Development Program incentive grant for their choice to build in Michigan rather than another state.

“Today’s investment announcement by Zoetis will foster a long-term positive impact on western Michigan’s economy and bring new jobs to the area. Numerous public and private partners deserve thanks for helping make this project happen, and we are pleased to support that collaboration,” said MEDC Chief Executive Officer Steve Arwood.

Zoetis currently employs approximately 300 people at its manufacturing facilities in Kalamazoo and Portage, including 265 dedicated directly to manufacturing.  

Renovations to the 524,000-square foot facility in Kalamazoo will expand production of Simparica(R) (sarolaner) Chewables, the oral flea and tick medication for dogs, which was approved by the U.S. Food and Drug Administration in February 2016.

The company expects to begin renovations later this month and to complete the project by early 2019.

This expansion isn’t a first for a company that continues to grow steadily.

Zoetis increased their manufacturing capabilities at their Nebraska facility in 2014.

The company was recently recognized by Forbes Magazine as one of America’s best employers for a second year in a row and made news with their acquisition of Nexvet Biopharma.

 

HEALTH - The Pet Effect Shares the Science of Pets and People

A growing body of evidence shows just how good pets are for people.

Zoetis, a founder of the Human Animal Bond Research Institute (HABRI), has launched the Pet Effect Campaign to share scientific evidence and research about this unique relationship between people and animals.

Anyone trying to convince their family or significant other to get a pet can visit their website where it’s easy to find detailed information about how pets have a positive impact on heart attack survival, allergy prevention, depression, blood pressure, autism and more.

Of course, researchers and writers will also find this website very valuable with its quick links to a variety of studies.

The Pet Effect will also share the message and the science that shows how veterinary medicine is an essential component of health for pets and people.

While the site is lighthearted, the information is scientific and impacts community health.

“Zoetis partnered with HABRI to bring veterinarians, pet owners and the general public The Pet Effect, a multi-faceted, educational campaign to promote a growing body of scientific research that shows how important the human-animal bond is for human health,” Mike McFarland, Group Director Companion Animal Marketing at Zoetis, says on their site.

“The purpose of the Pet Effect is to raise awareness and encourage conversation about why pets make us healthier and happier, and how veterinarians — the professionals who help keep pets healthy – are also key contributors to human health and public health.”

Resources on the website include posters, videos, infographics, brochures and flyers.

HEALTH - The Pet Effect Shares the Science of Pets and People

A growing body of evidence shows just how good pets are for people.

Zoetis, a founder of the Human Animal Bond Research Institute (HABRI), has launched the Pet Effect Campaign to share scientific evidence and research about this unique relationship between people and animals.

Anyone trying to convince their family or significant other to get a pet can visit their website where it’s easy to find detailed information about how pets have a positive impact on heart attack survival, allergy prevention, depression, blood pressure, autism and more.

Of course, researchers and writers will also find this website very valuable with its quick links to a variety of studies.

The Pet Effect will also share the message and the science that shows how veterinary medicine is an essential component of health for pets and people.

While the site is lighthearted, the information is scientific and impacts community health.

“Zoetis partnered with HABRI to bring veterinarians, pet owners and the general public The Pet Effect, a multi-faceted, educational campaign to promote a growing body of scientific research that shows how important the human-animal bond is for human health,” Mike McFarland, Group Director Companion Animal Marketing at Zoetis, says on their site.

“The purpose of the Pet Effect is to raise awareness and encourage conversation about why pets make us healthier and happier, and how veterinarians — the professionals who help keep pets healthy – are also key contributors to human health and public health.”

Resources on the website include posters, videos, infographics, brochures and flyers.

BUSINESS - Zoetis to Acquire Nexvet Biopharma

Zoetis Inc. and Nexvet Biopharma plc announced an agreement in which Zoetis, through a wholly owned subsidiary (“Zoetis Bidco”), will purchase Nexvet, an innovator in monoclonal antibody therapies for companion animals, for a purchase price of US$6.72 per share, representing an aggregate equity valuation of approximately US$85 million.

The acquisition will strengthen Zoetis’ pipeline of solutions for chronic pain management in dogs and cats, which represents an area of high-need in companion animal health.

The board of directors of Nexvet has unanimously approved the acquisition, which is being implemented by means of a scheme of arrangement, a statutory procedure under Irish law.

The acquisition is subject to approval by Nexvet’s shareholders and the Irish High Court and other customary conditions, and it is currently expected to be completed during the second half of 2017.

Nexvet is known for monoclonal antibody (mAb) therapies being developed for companion animals in pain and other therapeutic areas, and has research and development operations in Melbourne, Australia, a manufacturing facility in Tullamore, and a U.S. office in San Francisco.

“This acquisition is a strategic fit that brings to Zoetis an R&D organization that shares our commitment to industry-leading innovation,” said Dr. Alejandro Bernal, Executive Vice President and Group President, Strategy, Commercial and Business Development at Zoetis.

“It will strengthen our R&D pipeline in monoclonal antibodies and help sustain our category leadership in chronic pain management for companion animals, which is an area poised for innovation with new mAb therapies. The transaction demonstrates how we continue to invest to drive innovation and future growth.”

Zoetis has been a leader in the treatment of osteoarthritis pain and inflammation in dogs for two decades with the company’s Rimadyl® (carprofen), the first non-steroidal anti-inflammatory drug (NSAID) product approved for use in dogs.

Zoetis also developed and markets the NSAID product Trocoxil (mavacoxib), a COX-2 inhibitor approved in the European Union and other international markets to treat arthritis pain and inflammation in dogs.

Nexvet’s pipeline product ranevetmab, a mAb targeting nerve-growth factor (NGF) for treatment of chronic pain associated with osteoarthritis in dogs, would, upon approval, be the companion animal industry’s first monoclonal antibody therapy administered monthly by injection for chronic pain.

Ranevetmab would enable Zoetis to expand its portfolio of solutions for chronic pain in dogs.

Nexvet is also developing frunevetmab, a monoclonal antibody targeting NGF to treat chronic pain associated with osteoarthritis in cats.

Feline treatments for pain are limited, and frunevetmab could open up a new opportunity in feline pain that is underserved today.

“We are certain that Zoetis, with its leadership in R&D, high quality manufacturing, marketing excellence, global scale and strong customer relationships, is the ideal company to guide our monoclonal antibody candidates through development into commercialization,” said Dr. George Gunn, Chairman of the Board of Nexvet.

“We see the integration with Zoetis as the logical next step to realize our ambition to bring groundbreaking antibody therapeutics to market.”

FDA Approves New Canine Medications

Two new canine medications were approved by the United States Food and Drug Administration (FDA) in June 2015.

Coraxis™

Coraxis is produced by Bayer HealthCare LLC, Animal Health Division and was approved on June 6th. According to the FDA this medication is used “For the prevention of heartworm disease caused by Dirofilaria immitis, and for the treatment and control of Ancylostoma caninum (adults, immature adults, and fourth stage larvae), Uncinaria stenocephala (adults, immature adults, and fourth stage larvae), Toxocara canis (adults and fourth stage larvae), Toxascaris leonina (adults), and Trichuris vulpis (adults) in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 pounds.”

Cerenia®

Cerenia is produced by Zoetis Inc. and was approved on June 17th. According to the FDA, “This supplement provides for extension of the number of days of consecutive use from “5 days” to “until resolution of acute vomiting” for the prevention of acute vomiting in dogs 7 months and older.”

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